The purpose of this Notice is to clarify specific issues pertinent to the scientific scope and requirements of a recently released Program Announcement PAR-08-225 entitled “Quantitative Imaging for Evaluation of Responses to Cancer Therapies (U01).” That funding opportunity has been designed to promote research and development of quantitative imaging methods pertinent to tumor response to therapies in clinical trial settings, with the overall goal of facilitating clinical decision-making.

Responding to inquiries from various prospective applicants, the NCI clarifies the following six points pertinent to PAR-08-225:

Whereas the primary emphasis of PAR-08-225 is on the evaluation of responses to therapy, research projects involving quantitative imaging for prediction of therapeutic responses are also appropriate.

Testing of quantitative imaging tools in Phase 3 clinical trials can be included for their validation as clinical decision-making tools.

PAR-08-225 allows budget requests to cover costs of adding correlative imaging studies to clinical trials. Applicants must be aware that the stated restriction that the costs of the actual clinical trials will not be covered will be enforced without exceptions.

PAR-08-225 encourages applicants to take advantage of the available option of multiple Program Directors/Principal Investigators (PD/PIs) as the opportunity for shared leadership by imaging scientists and clinical researchers. Nonetheless, a single PD/PI may still be proposed, if preferred. In that case, the PI may be either an imaging scientist or a clinical researcher (e.g., a research radiologist or oncologist).

Applicants are expected to provide brief Data Sharing Plans. However, if imaging tools are tested in clinical trials, the plans do not have to include certain types of information about the trials that are not directly relevant to the imaging tools as such. For example, awardees reporting the results for the quantitative imaging tools tested for performance in therapeutic clinical trials will NOT be required to disclose the identities of specific therapeutic agents being used in these clinical trials.

Applications submitted in response to PAR-08-225 must use paper format and detailed, non-modular budget format.

Inquiries

Direct inquiries regarding this Notice to the involved NCI Program Directors: